510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 1037 of 3531

510(k) clearances, page 1037 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093449	Mini Lap Retractors	Mini Lap Technologies, Inc.	GCJ	Class II	2010-02-12
K093338	Self Adhesive Composite Luting Cement	Dmg USA, Inc.	EMA	Class II	2010-02-12
K093208	Simpliseal	Discus Dental LLC	KIF	Class II	2010-02-12
K093192	Flochec Photo Plethysmographic Device	Advanced Vascular Dynamics	JOM	Class II	2010-02-12
K093138	Mt9000 Series Electro-Stimulator, Models Mt9000, Mt9002, Mt9001, Mt9004 and Mt9003	Shenzhen Dongdixin Technology Co., Ltd.	IPF	Class II	2010-02-12
K093106	Endoscope Reprocessor Oer-Pro	Olympus Medical Systems Corp.	FEB	Class II	2010-02-12
K093027	Straumann Rc Temporary Abutments	Straumann USA, LLC	DZE	Class II	2010-02-12
K093004	Impress Angiographic Catheter with Hydrophilic Coating	Merit Medical Systems, Inc.	DQO	Class II	2010-02-12
K092835	Comfortgel Nasal Mask	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2010-02-12
K092421	Alphahysteroscope, Fiberoptic, Operative and Diagnostic	Gimmi GmbH	HIH	Class II	2010-02-12
K092192	Waypoint Stereotactic System	FHC, Inc.	HAW	Class II	2010-02-12
K090250	Electro-Light Therapy	Hill Laboratories	ILY	Class II	2010-02-11
K093637	Jms Blunt a. V. Fistula Needle Set with Site Preparation Tool Model 820-5300, 820-6300 and 820-7300	JMS North America Corp.	FIE	Class II	2010-02-09
K093379	Tcx-I-Dv Remote Care Management System	Bl Healthcare, Inc.	KDI	Class II	2010-02-09
K093861	Iq 20 Series Analyzer, Iq 200 Series System, Nad Iq Lamina Cradle	Iris International, Inc.	LKM	Class II	2010-02-05
K093567	Active Knee Total Knee Replacement System	Anova Implant Solutions, LLC	JWH	Class II	2010-02-05
K093476	Amplatzer Torq Vue 2 Delivery Sheath Model 9-Tv2-05F120, Model 9-Tv2-06F120, Modeltv-2-07F120	Abbott Medical	DQY	Class II	2010-02-05
K093154	Tcm Tosca Monitoring System, Tcm Combim Monitoring System	Radiometer Medical ApS	LKD	Class II	2010-02-05
K093081	Pocket Bvm	Microbvm Systems, Ltd.	BTM	Class II	2010-02-05
K093007	Entellus Medical Balloon Device	Entellus Medical, Inc.	LRC	Class I	2010-02-05
K093005	Fora G72 Blodo Glucose Monitoring System/td-4264 Blood Glucose Monitoring System, Model Td-4264	Taidoc Technology Corporation	NBW	Class II	2010-02-05
K092142	Sport-Elec Body Control System Bs	Sport-Elec	NGX	Class II	2010-02-05
K091769	Trust Dam	Line One Laboratories	MSC	Class II	2010-02-05
K091757	OTC TENS for Arm and Leg Pain Relief, Model Wl-2407	Well-Life Healthcare Limited	NUH	Class II	2010-02-05
K091493	Ortho Select Bone Plates and Screw System	Ortho Select Implant Technology Gesellschaft	HRS	Class II	2010-02-05
K091210	Acecide-C High Level Disinfectant and Sterilant	Best Sanitizers, Inc.	MED	Class II	2010-02-05
K090264	Hemosil D-Dimer Hs 500, Controls	Instrumentation Laboratory Co.	DAP	Class II	2010-02-05
K100192	Strong Dental Handpieces	Saeshin Precision Co., Ltd.	EGS	Class I	2010-02-04
K100070	Uniplate Anterior Cervical Plate System	DePuy Spine, Inc.	KWQ	Class II	2010-02-04
K100044	Firebird Spinal Fixation System, Firebird Side-Loading Body	Blackstone	NKB	Class II	2010-02-04
K093927	6F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central Venous Catheter	C.R. Bard Inc	LJS	Class II	2010-02-04
K093846	Longevity It Highly Crosslinked Polyethylene Elevated Liners	Zimmer GmbH	LZO	Class II	2010-02-04
K093688	Canon, Model Urs-50Rf	Virtual Imaging, Inc.	OWB	Class II	2010-02-04
K093444	Exapacs	Medincom Technology Corp	LLZ	Class II	2010-02-04
K093142	Target Detachable Coils and Inzone Detachment System	Boston Scientific Corporation	HCG	Class II	2010-02-04
K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	HRX	Class II	2010-02-04
K093059	Select Defense Dental Pit and Fissure Sealant	Classone Orthodontics, Inc.	EBC	Class II	2010-02-04
K092918	Pari Vios	Pari Respiratory Equipment, Inc.	CAF	Class II	2010-02-04
K092836	Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair System/12 Degree, Model 228141	DePuy Mitek, Inc.	MBI	Class II	2010-02-04
K092800	Anti-Wrinkle (Aging) Light, Model Aal	LED Intellectual Properties LLC	ONE	Class II	2010-02-04
K092649	Elecsys Probnp II Stat Immunoassay and Elecsys Probnp II Calset, Models 05390109-160, 04842472-190	Roche Diagnostics GmbH	NBC	Class II	2010-02-04
K092574	Esl Spinal System	Ebi, LLC	MAX	Class II	2010-02-04
K092531	Spine360 Anterior Cervical Plate System	Spine360	KWQ	Class II	2010-02-04
K092527	Nexus Injection Site, Model Nis-8	Nexus Medical, LLC	FPA	Class II	2010-02-04
K091522	Immulisa Celiac G+ (Gliadin) Iga and Igg Antibody Elisa	Immco Diagnostics, Inc.	MST	Class II	2010-02-04
K091363	Compressor Filter, Models Ag1038831, Hcf100,bf900,bf910,bf950, Ll201, Ll202, Ll205, Bacteria Filter	AG Industries LLC	CAH	Class II	2010-02-04
K091077	Optease Vena Cava Filter and Retrieval Catheter	Cordis Corp., A Johnson & Johnson Co.	DTK	Class II	2010-02-04
K090609	Okmeter Match Blood Glucose Monitoring System	OK Biotech Co., Ltd.	NBW	Class II	2010-02-04
K082525	Corin Metafix Femoral Stem	Corin USA	LZO	Class II	2010-02-04
K093572	R650 Qdasm Collimator	Omega Medical Imaging, LLC	IZW	Class II	2010-02-03